MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number	VICM5_13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uveitis (2122)
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon reports a case of uveitis three weeks after surgery.Per updated information the patient is doing well and the treatment ( eye drops) has solved the issue.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 -5.50 diopter lens into the patients right eye (od) on (b)(6) 2023.Reportedly, iritis/uveitis/cme was observed three weeks after surgery.Per updated information the patient is doing well and the treatment (eye drops) has solved the issue.On 11-nov-2023 excessive vaulting was reported.On (b)(6) 2023 the lens was explanted.This resolved the issue.Additional information reportedly, approx 6 weeks post surgery all was perfect.Arthritis was first diagnosed outside the clinic later dr.Bechmann wrote in the patient file that there was no evidence of panuveitis.On sep6th a cme on both eyes was shown.Patient got "triam" (triamcinolon) parabulbar odos.On sep20th patient got much better, oct10th all was fine again.On nov11th vaulting on od 1020 microns and os 912 micrones ucva 20/25 odos.A work order search found 3 similar complaints.Claim (b)(4) is for the opposite eye (os) and claim # (b)(4) are duplicate claims of (b)(4).No similar complaint type events reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
Additional information: h3 - device evaluation: the lens was returned dry in a microcentrifuge vial with residue/debris on the lens.Visual inspection found the haptic broken and bent with residue on the lens.Dimensional inspection found the lens to be within specifications.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17877870
• Report Number: 2023826-2023-04418
• Device Sequence Number: 12616994
• Product Code: MTA
• UDI-Device Identifier: 00840311300846
• UDI-Public: 00840311300846
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: VICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 03/27/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 01/24/2024; 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Unknown